FDA 510(k) Application Details - K031207

Device Classification Name Lock, Wire, And Ligature, Intraoral

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510(K) Number K031207
Device Name Lock, Wire, And Ligature, Intraoral
Applicant CASEY SURGICAL, LLC
200 NE MULBERRY
SUITE 200
LEE'S SUMMIT, MO 64086 US
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Contact JAMES E STANLEY
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Regulation Number 872.4600

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Classification Product Code DYX
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Date Received 04/16/2003
Decision Date 07/15/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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